I have written a book on the politics of autism policy. Building on this research, this blog offers insights, analysis, and facts about recent events. If you have advice, tips, or comments, please get in touch with me at jpitney@cmc.edu

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Friday, March 9, 2018

Myth about FDA Warning Lives On

One problem is that a good deal of the solid research about autism lies in academic journals behind an Internet paywall, open only to people who have a university library card or can afford the journals’ exorbitant prices ($35 or more per article). Says neuroscientist Sophia Colamarino: “In today’s information age, where essentially anything said by anyone can be made accessible within a matter of moments, it is unfortunate that families have easy access to all BUT the most scientifically valid information, that which can be found in scientifically reviewed research literature.” NIH and Autism Speaks have tried to remedy this situation by requiring its research grant recipients to put any resulting peer-reviewed research papers on the PubMed Central online archive, but this policy affects only a fraction of the literature on autism.

Autism was listed as one of many “adverse events” on the 2005 label of Sanofi Pasteur’s Tripedia childhood vaccine for diphtheria, tetanus and pertussis. When the vaccine was first approved, such reports were generated voluntarily by consumers and were automatically added to the FDA label, even if there was no plausible connection to the product.

The 2005 label notes that such reports do not “establish a causal relationship” to the vaccine. Since then, the FDA has changed its labeling rules and now only includes adverse events “for which there is some basis to believe there is a causal relationship,” the agency said in a statement.

Sanofi Pasteur stopped making the vaccine years ago, and its last shipment of it was in 2012.